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DepressionPRIME-PKNCT05767840

Integrated Mental Healthcare Plan for Management of Depression and Self-harm in Pakistan

A study testing psychological interventions in people with Depression and Self Harm, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Aims: 1. To describe the process of developing a feasible district mental healthcare plan (MHCP) for depression, self-harm and suicide prevention, and 2. To describe its enabling intervention packages and components to be delivered at the Basic Health Units in Thatta district. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Self Harm
What is being tested?
psychological interventions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePakistan
Study dates
1 Feb 2024to 30 Jan 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients aged 18 and above presenting to recruiting health facilities will be assessed by the research team for depression (positive) and/or history of self-harm (positive

Who cannot join

  • Patients below 18 years of age,
  • Patients taking medication for/ having a diagnosis of substance abuse, severe mental/physical disability/ comorbidity, whereby they are unable to participate in the interview.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • District health facility

    Thatta, Sindh

Other trials in Pakistan

About this study

Official title: Development and Pilot Testing of an Integrated Mental Healthcare Plan for Management of Depression and Self-harm in a Rural District (Thatta) in Pakistan

Aims:

  1. To describe the process of developing a feasible district mental healthcare plan (MHCP) for depression, self-harm and suicide prevention, and
  2. To describe its enabling intervention packages and components to be delivered at the Basic Health Units in Thatta district.

The proposed study will be a pilot implementation with nested qualitative component. The study will also involve situational analysis for proposed study site and Theory of Change workshops with key stakeholders.

This study is a replication of the methods used in the development of a district mental healthcare plan in Uganda (Kigozi et al., 2016).

Read the detailed description

Mental neurological and substance use (MNS) disorders contribute significantly to global burden of disease. The WHO Mental Health Action Programme (MhGAP) taking a life course approach has developed an intervention guide to scale up services in low and middle income countries (LMICs) focusing on priority mental health conditions in adults and older adults.

The gap between the individuals in need of mental health interventions and those who actually receive such care remains very large. To reduce the treatment gap, the WHO Mental Health Action Plan (WHO, 2017) strongly recommended assessment, diagnosis and treatment of MNS in community settings and primary healthcare (PHC). Central to this agenda is the WHO Mental Health Gap Action Programme (mhGAP) and intervention guide (IG) (WHO, 2010) which is an evidence based tool.

The proposed project aims to integrate the adapted WHO-mhGap-IG for depression, self-harm and suicide prevention into the community and primary settings in Thatta (situated in the province of Sindh, Pakistan).

Depression and self-harm are selected priority conditions for the proposed study.

In order to collect information and detailed cross-sectional data on health and factors that can influence health of Thatta district, a situational analysis tool will be used.

Both one to one in-depth interviews as well as focus groups will be conducted with stakeholders to explore possible barriers and facilitators of testing the feasibility of adapted mhGap-IG for depression and self-harm in Thatta.

Pilot study will be conducted using the mhGAP-Intervention Guide (mhGAP-IG) (two modules: Depression, self harm and suicide prevention)

Being tested
psychological interventions
Keywords
treatment gap, mental health, primary care, task shifting, mhGap, Pakistan
Medical subject headings
Depression, Self-Injurious Behavior, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • psychological interventionsOther

    Also called mhGap-IG

    mhGap-IG Depression and self-harm module. For participants identified as has having depression, following interventions will be offered depending on nature of the participants.

    1. Khushi Aur Khatoon - for the treatment of depression and anxiety
    2. Learning through Play Plus - 10-session group intervention that integrates parental information about child development and Cognitive Behavior Therapy
    3. Problem management Plus (PM+) - PM+ is for adults suffering from symptoms of common mental health problems , as well as self-identified practical problems.

    Cohort identified as having a recent history of self-harm will receive; Culturally Adapted Manual Assisted Problem Solving Intervention (CMAP) - This intervention is a manual-assisted intervention, adapted from a self-help guide called Life After Self-Harm.

Study groups in NCT05767840
Study groupRoleWhat they receive
mgGap-IGExperimentalMhGap-IG intervention to be delivered to depression and self-harm cohorts
Receives: Other: psychological interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Piloting log to record number of patients with depression and or self-harm episode, treatment initiated and patients referred

    Culturally Adapted Manual Assisted Problem Solving Intervention (CMAP) - This intervention is a manual-assisted intervention which has been adapted from a self-help guide called Life After Self-Harm based on the principles of CBT

    Measured: Recruitment From First month of study to the end of thirst month of the study start date.

Secondary outcomes (7)

  1. Patient Health Questionnaire

    This is a10 item questionnaire with a total score ranging from 1-4 indicates minimal depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, and 20-27 severe depression. A cut-off score of 10 and above indicate high likelihood of presence of depression.

    Measured: Change in scores from baseline to 3rd-month follow-up on PHQ-9

  2. Generalised Anxiety Disorder scale

    This is a 7-item scale. GAD-7 total score for the seven items ranges from 0 to 21.0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety. A cut-off score of 10 and above indicate high likelihood of presence of anxiety.

    Measured: Change in scores from baseline to 3rd-month follow-up on GAD-7

  3. Deliberate Self-Harm Inventory

    DSHI will be used to collect information about episode of self-harm. is a 17-item self-report questionnaire developed to assess deliberate self-harm. It is behaviorally based and assesses aspects of deliberate self-harm such as frequency, severity, duration, and type of self-harming behavior

    Measured: Repetition of a self-harm episode from baseline to end of 3rd month post-baseline

  4. Oslo - 3 items social support scale

    Oslo-3 social support scale is a short three item rating scale. This scale assesses relationship with friends, family and neighbors. Each item is scored on a 5-point rating scale, and the total score ranges from 3 to 15, with high scores indicating greater level of support.

    Measured: Change in scores from baseline to 3rd-month follow-up on social support

  5. Life Events Checklist

    The domains that accounted for most of the life events and difficulties will be included and rated categorically as present or not in the previous 12 months.

    Measured: Number of stressful events identified by each participant as present in last 12 months

  6. EuroQoL-5 Dimensions

    This is a standardized instrument to measure health-related quality of life. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression)

    Measured: Change in scores from baseline to 3rd-month follow-up on EQ-5D

  7. Client Services Receipt Inventory

    Participants will be asked to give a detailed description of the use of health services (including the informal sector faith healers/Imams) in last 3 months.

    Measured: Change in health service utilization from baseline to 3 month follow-up recorded through CSRI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2023
  2. Study start1 Feb 2024
  3. Primary completion30 Apr 2024
  4. Study completion30 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05767840
Sponsor's protocol ID
PRIME-PK
Acronym
PRIME-PK
Status last verified
Dec 2024
First submitted
28 Feb 2023
Last updated
10 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only anonymized data will be shared on request

Publications

  • Kigozi FN, Kizza D, Nakku J, Ssebunnya J, Ndyanabangi S, Nakiganda B, Lund C, Patel V. Development of a district mental healthcare plan in Uganda. Br J Psychiatry. 2016 Jan;208 Suppl 56(Suppl 56):s40-6. doi: 10.1192/bjp.bp.114.153742. Epub 2015 Oct 7.

    PubMed 26447171

Questions about this trial

What is this clinical trial studying?

A study testing psychological interventions in people with Depression and Self Harm, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Piloting log to record number of patients with depression and or self-harm episode, treatment initiated and patients referred (time frame: Recruitment From First month of study to the end of thirst month of the study start date.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05767840, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.

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